Method for packaging elongated surgical device

ABSTRACT

A package for an elongate surgical device, such as a catheter, includes an elongate tube formed into a coil configuration with a first coil portion disposed adjacent to a second coil portion. A thermal weld bonds the coil portions in a fixed relationship and with a strength sufficient to prevent peeling the first coil portion from the second coil portion. The surgical device can then be loaded into the tube, pouched and sterilized for ultimate distribution. In an associated method, the tube is coiled on a turntable and moved relative to heating stations where the thermal bonds can be formed.

PRIORITY CLAIM

This is a divisional application of application Ser. No. 10/614,546filed on Jul. 3, 2003 now U.S. Pat. No. 7,234,597.

This patent application claims the benefit of the priority date of U.S.Provisional Patent Application Ser. No. 60/408,085, filed on Sep. 3,2002 and entitled GUIDEWIRE/CATHETER PACKAGING TUBE pursuant to 35 USC119, the entire contents of this provisional patent application arehereby expressly incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to packages for surgicaldevices, and more specifically to packages including a tube forpackaging elongate surgical devices such as catheters and guidewires.

DISCUSSION OF THE PRIOR ART AND RELATED INFORMATION

There are many surgical devices that are designed to navigate torturousconduits within the human body. Representative of these devices arecatheters and guidewires that typically have diameters in a range of 1French to 20 French and lengths in a range of 12 to 200 inches. Theseare flexible devices capable of being formed into smaller volumes tofacilitate packaging and distribution of the products. One form ofpackaging that is particularly common includes a coiled tube having alumen into which the surgical device can be loaded without kinking ordistorting the device.

In the past, formation of this coiled tube package has been difficult asthe coils have a natural tendency to separate. In an effort to maintainthe coiled configuration of the tube, various mechanical clips have beenformed to individually engage the coils and hold them in closeproximity. By maintaining each of the coils in a fixed relationship withthe clip, the coiled configuration of the tube can be looselymaintained.

After the coiled tube has been formed and the device has been loaded,the device and tube is enclosed in a pouch and sealed for sterilizationand ultimate distribution of the product. The coiled tube is typicallysupplied to the manufacturer of the surgical device. The device has thenbeen loaded into the coiled tube and a lid is sealed over the tube andthermoformed tray to provide a sterilizable and hermetically sealedchamber for the surgical device.

Unfortunately, the mechanical clips have not provided a satisfactorymeans for maintaining the coiled configuration of the tube. The clipshave been formed with sharp edges and points, which have tended topuncture the pouch thereby compromising the sterility of the device.These clips have added significantly to the cost of the packaging, andhave been both labor intensive and time consuming to apply. Furthermore,they have not provided a rigid structure for maintaining the coiledconfiguration of the tube. In addition, retention accessories such asinjection molded cups, connectors, clips, thermal formed trays and thelike have been used to facilitate mechanical retention of component andaccessories for said device. The retention accessories are typicallyaffixed by means of snap fit, gluing and chemical bonding.

SUMMARY OF THE INVENTION

In accordance with the present invention, these deficiencies of previouscoiled packages have been overcome by providing a thermal bond betweenportions of the adjacent tube coils. The bond can be formed as a single,continuous spiral weld or as a plurality of spot welds. In either case,adjacent coils in the coiled stack, or profile, are bonded together in afixed relationship, which greatly facilitates the remaining steps in thepackaging process.

The tube can be coiled in many different configurations, each beingstabilized with one or more of the thermal bonds. For example, the coilcan be wound in a spiral configuration that can be formed in a singleplane. In this configuration, the coils of the spiral have diametersthat increase outwardly. In another embodiment, the coils are formedwith a constant diameter so that the coil configuration forms acylinder. In this configuration, the thermal bonds can also be formedbetween adjacent coils to maintain a cylindrical configuration. Thesetwo configurations can be used in a third combination for packaging morethan one elongate device, each in a separate coiled tube. For example, aguidewire might be packaged in a first tube formed as a spiral in afirst plane, while the catheter might be packaged in a second tubeformed as a spiral in a second plane and stacked on top of the firsttube. In this case, thermal bonds can be formed between the two tubes aswell as between the coils of the tubes.

Thermal bonds can also be used to attach the coiled tubes to a backingcard which acts as a labeling surface and a retention element and alsoto attach stand alone retention accessories to the tubes. Thus, thethermal bonds aid significantly in forming a rigid package that canultimately be enclosed in a pouch without fear of compromising theintegrity of the pouch.

In one aspect, the invention includes a package for an elongate surgicaldevice where the package is formed with an elongate tube having wallsdefining a lumen between a first end and a second end of the tube. Thetube is formed into a coiled configuration with a first coil portiondisposed adjacent to a second coil portion. A thermal weld bonds thefirst coil portion to the second coil portion in a fixed relationship,and provides a strength sufficient to prevent peeling the first coilportion from the second coil portion.

Another aspect of the invention includes a method for packaging anelongate surgical device having an outside diameter. An elongate tube isprovided having a tube wall with an inside diameter greater the outsidediameter of the device. This tube is coiled to move a first tube portioninto an adjacent relationship with a second tube portion. These twoadjacent tube portions can then be thermally bonded so that the walls ofthe adjacent tube portions are maintained in a fixed relationshipwithout occluding the tube. One or more of these bonds can be used tomaintain the tube in a coiled configuration. A bridge can also be usedto thermally bond the coils in the desired fixed relationship. A backingcard formed of the same material as the tubing can be used to carry thecoiled tube and otherwise facilitate components and accessories duringthe packaging process. The coils can be formed into a single layer withadjacent coils increasing outwardly in diameter. Alternatively, thecoils can be formed with a constant diameter to form a stack of thecoils. In either configuration, the coils can be formed from a singletube for packaging a single device, or multiple tubes for packagingmultiple devices.

In a further aspect of the invention, a package is formed by providingan elongate tube having walls defining a lumen between a first end and asecond end of the tube. The first end of the tube is attached to afixture having at least one heating station and a turntable rotatablerelative to the heating station. The turntable can then be rotated toform the tube into at least coil having adjacent coiled portions. Bybonding the adjacent coiled portions at the heating (thermal transfer)station, the coiled configuration of the tube can be permanentlymaintained. On the turntable, the tube can be formed into multiple coilshaving a single layer or multiple coils formed as a stack with multiplelayers. The adjacent coiled portions can be heated by directing heatedair onto the coiled portions, by contacting the coiled portions with aheating element, by directing a laser beam onto the coiled portions andother thermal transfer methods. In all cases, the material of the coilsbecomes plasticized to form the thermal bonds.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a medical device package of the presentinvention;

FIG. 2 is a cross section view taken along lines 2-2 of FIG. 1, with theaddition of a guidewire/catheter and enclosing pouch;

FIG. 3 is a is a side elevation view of a catheter representative of anyelongate surgical device;

FIG. 4 is a side elevation view of a tube used in the packageillustrated in FIG. 1.

FIG. 5 is a top plan view illustrating formation of a thermal bondbetween adjacent coils of the tube;

FIG. 6 is a cross section view taken along lines 6-6 of FIG. 5.

FIG. 7 is a top plan view illustrating use of bridges to form the rigidcoil tube configuration;

FIG. 8 is a cross section view taken along lines 8-8 of FIG. 7;

FIG. 9 is a top plan view of a further embodiment including stacks oftube coils;

FIG. 10 is a cross section view taken along lines 10-10 of FIG. 9illustrating multiple coils, each disposed in an associated plane;

FIG. 11 is a top plan view of a coil configuration including multiplecoil stacks of multiple tubes;

FIG. 12 is a cross section view taken along lines 12-12 of FIG. 11;

FIG. 13 is a top plan view illustrating a retention accessory thermallybonded to a coiled tube;

FIG. 14 is a top plan view illustrating the coiled tube thermally bondedto a backing card acting as a retention accessory and labeling surface;and

FIG. 15 is a top plan view of a fixture illustrating steps in themanufacture of the coiled tubing and associated thermal bonds.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OF THEINVENTION

A guidewire/catheter package is illustrated in FIGS. 1 and 2 anddesignated by the reference numeral 10. Although the package 10 isspecifically adapted to retain, transport, distribute, and deliver acatheter or guidewire 12, it will be apparent that the package 10 can beadapted for use with any flexible elongate surgical instrument.

In the illustrated embodiment, the package 10 includes at least one tube14 having a lumen 16 (best shown in FIG. 2) that extends betweenopposing ends 18 and 21. The tube 14 is formed as a coil assembly 23. Inorder to facilitate the attachment of clips, connectors, adapters orcomponents commonly used for the retention and assembly of othersurgical devices and peripheral components, the coil assembly 23 may becarried on a backing card 25 with component retention capabilities. Forexample, the backing card 25 may be provided with retaining mechanisms26 configured to retain such components. For instance, the retainingmechanisms 26 may comprise tongue-and-groove portions cut out of thebacking card 25 itself. As a further example, a retention accessory 27may alternatively or additionally be coupled to end 18 and/or 21 of thetube 14 to facilitate the attachment of such components. It is to beexpressly understood that a backing card 25 and a retention accessory 27may be used independently of, or in combination with, each other.

In the coil assembly 23, tube portions 28 and 29 can be brought into anadjacent relationship. Thermal bonds 30 can then be created betweenthese tube portions 28 and 29 to maintain the coiled configuration.Thermal bonds 32 can also be created between the coil assembly 23 andthe backing card 25. Similarly, the retention accessory 27 can beattached to the end 18 and/or 21 of the tube 14 by a thermal bond 34,and attached to the backing 25 by an optional thermal bond 36.

As an example and not by way of limitation, thermal bonding can beformed using a process utilizing means of heating including but notlimited to, heating elements, hot air, heaters, heating plates, laser orthe combination thereof (herein referred to as “thermal bonds”) wherethe material plasticizes and conjoins the surfaces of the tubing coilstogether. The process of thermally bonding the tubing together isapplied to join singular or a plurality of tubes to form a coiledpackaging, holding and dispensing tube (“packaging tube”) that is notintended to be separated. The thermal bonds may be intermittent,continuous from tube to tube or may be formed by the application of a“bridge bond” where a separate piece of like material is thermallybonded to a side of the coiled tubing conjoining all coils together.Equipment used to manufacture the package 10 may utilize thermal/heatingelements that can be in a singular processing configuration or in amultiple processing configuration allowing for higher productionthroughput and can be manually operated or automated to increase cycletime

The manufacturer of the guidewire or catheter 12 may either manufacturethe package or purchase the package from an outside vendor. In eithercase, the manufacturer will be responsible for loading the guidewire orcatheter 12 into the coil assembly 23. Typically, one end of theguidewire or catheter 12 is inserted into the end 18 of the tube 14 andpushed through the lumen 16 of the tube 14 until the entire catheter 12is substantially enclosed by the tube 14. The resulting subassemblyincluding the backing card 25, coil assembly 23, retention accessory 27(if any), and the catheter 12 can then be inserted into a pouch 31 andsuitably sealed to facilitate sterilization, for example, by gammaethylene oxide, e-beam, or other validated sterilization technique.

The features and advantages of the present invention can be bestunderstood with an appreciation of the nature of the guidewire orcatheter 12, which is illustrated in FIG. 3. The elongate surgicaldevice represented by the catheter 12 may have a diameter ranging inFrench sizes from 1 French to 20 French. This narrow diameter willusually be maintained along the body of the catheter and through adistal end 41. At a proximal end 42, the catheter may be provided, forexample, with lures, connectors, stylets, mandrels, needles, tubing, orin the illustrated embodiment, a hub 43. The length of the guidewire orcatheter 12 may be in a range of 12 to 200 inches. In order to providefor a package 10 of reduced size, it is desirable to bend the catheter12 without kinking or in any other way degrading its structuralperformance.

A length of the tube 14 is illustrated in FIG. 4. In this case, the tube14 has a cylindrical configuration, but it may also be tapered betweenthe ends 18 and 21. Thus, the tube 14 may be extruded in a uniform ortapered cross section to accommodate various surgical deviceconfigurations, and provided with an overall length that typicallyexceeds that of the surgical device. Thus, the tube 14 may have a lengthin a range slightly greater than 12 and 200 inches, with the lumen 16having a diameter of about 0.030 to 0.300 inches. Outer diameters of thetube 14 will typically range between 0.100 and 0.500 inches. A typicalwall thickness of the tube 14 will be in a range between 0.010 and 0.100inches. In certain preferred embodiments of the invention, the coilassembly 23 will have a diameter between 3 inches and 24 inches. Thisdiameter, of course, will depend on the stacking tolerance of the coilassembly 23 and the wall thickness of the tube 14.

In the plan view of FIG. 5 and cross section view of FIG. 6, the coilassembly 23 is illustrated in a spiral configuration wherein the tube 14is coiled in a single plane 50, as shown in FIG. 6. In thisconfiguration, the tube 14 is provided with multiple coils 52, 54, and56, which increase in diameter outwardly from the end 21 to the end 18.With this configuration, the thermal bonds 30 are formed betweenadjacent coils such as between the coils 52 and 54 and between the coils54 and 56. These bonds 30 maintain the coils 52, 54, and 56 in a fixedrelationship so that they cannot be separated or peeled.

The bonds 30 between the coils 52, 54 and 56, as well as the bonds 32,34, and 36, can be formed with a variety of techniques as shown in FIG.5. Hot air from a nozzle 58 can be directed at the interface betweenadjacent coils, for example. As an alternative, the thermal bonds can beformed using a heating element, which might include a heating probe 61or heating plate, for example. As a further alternative, a laser 63might be used to form the thermal bonds 30, 32, 34, and 36.

These heating devices 58, 61, and 63 are particularly advantageous whenthe structures to be bonded are formed of the same plastic material suchas polyethylene, polypropylene, polyvinyl chloride, or otherpoly-related material. As the materials of the various elements areheated, they tend to plasticize, conjoining the surfaces of the elementsin a fixed, non-peelable relationship. It is of particular importancewith respect to the thermal bonds 30 that the adjacent walls of the tube14 be bonded without occluding the lumen 16.

The embodiment of FIGS. 7 and 8 is similar to that of FIGS. 5 and 6 inthat the coils 52, 54, and 56 are spiraled in the single plane 50. Inthis case, however, the thermal bonds are not formed directly betweenthe coils 52, 54, and 56, but are individually formed between each coiland a pair of bridges 65 and 67. The bridges 65, 67 in this case aremerely pieces of plastic formed of a material common to the tube 14 andlaid along a side of the coils 52, 54, and 56. One of thermal bonds 30can be formed at the junction of each of the coils 52, 54, and 56 withthe bridges 65 and 67. A further embodiment of a coil assembly 23 isillustrated in FIGS. 9 and 10. As shown in FIGS. 9 and 10, a tube 14extends from one end 18 to an opposite end 21 to form stacked coils 70,72, 74, each with an associated plane 76, 78, 81, respectively.

A further configuration of the coil assembly 23 is illustrated in theplan view of FIG. 11 and cross section view of FIG. 12. This assembly 23is of particular advantage when more than one surgical device, such as aguidewire and a catheter, are to be packaged together. This is often thecase when a particular guidewire is to be used with a particularcatheter. In the illustrated embodiment, two separate package tubes areprovided, each having a pair of ends. Thus, the tube 14, with its ends18 and 21, is illustrated in FIG. 11 in a first spiral and single plane50. In addition, a second tube 85, having ends 87 and 90, is illustratedin a second spiral and second plane 92. In the illustrated embodiment,the outer ends 18 and 87 of the tubes 14 and 85 respectively, arepositioned on opposite sides of the coil assembly 23.

After the coil assembly 23 has been formed and appropriately bonded, theretention accessory 27 can be coupled to the end 18 and/or 21 of thetube 14 as illustrated in FIG. 13. As noted, the retention accessories27 are individually designed and manufactured typically by die cutting,to accommodate various device components, such as the hub 43 (FIG. 3).The retention accessory may be coupled to the coil assembly 23 bystrapping, snapping, gluing, mechanical bonding, or thermal bonding aspreviously discussed.

Alternatively, in FIG. 14, retention capabilities may be provided in thebacking 25 by forming, for example, retaining mechanisms 26. Theseretaining mechanisms 26 may be formed integrally the backing, forinstance, by simply making cut-outs.

A preferred fixture 93 for forming the coil assembly 23 with the thermalbonds 30 is illustrated in the top plan view of FIG. 15. In this case,the fixture 93 includes a turntable 94 that is rotatable relative to apair of opposing heat stations 96 and 98. Heating elements, such as hotair nozzles 101 and 103, are provided in each of the heating stations 96and 98, respectively. In operation, the end 18 of the tube 14 isinitially positioned against a stop 105, and the turntable 94 may berotated in the direction of arrow 107. After or concurrent to the coilsof the tube establishing an adjacent relationship, the nozzles 101 and103 can be activated to create individual thermal welds 30. This heatingstep may be accomplished with the turntable 94, either stationary orrotating. In a rotating mode, the nozzles 101 and 103 can beintermittently activated to create the spot welds 30 or can becontinuously activated to create a single continuous bond between theadjacent coils of the tube 14. If the welds 30 are formed with theturntable 94 in a stationary mode, the nozzles 101 and 103 can bemanually adjusted to the coil interface. Alternatively, if the welds 30are formed with the turntable 94 in a rotation mode, they can beautomatically adjusted to follow the spiral interface of the coils.

In the preferred embodiments, the tube 14, backing card 25 and retainingaccessory 27 are all composed of a common material in order to enablethe thermal bonding as discussed above. As an example and not by way oflimitation, the common material may comprise polyethylene.

Notwithstanding the forgoing detailed description of preferredembodiments, it will be apparent that many alterations and modificationsmay be made by those having ordinary skill in the art without departingfrom the spirit and scope of the invention. Therefore, it must beunderstood that the illustrated embodiments have been set forth only forthe purposes of examples and that they should not be taken as limitingthe invention as defined by the following claims. For example,notwithstanding the fact that the elements of a claim are set forthbelow in a certain combination, it must be expressly understood that theinvention includes other combinations of fewer, more or differentelements.

Also, the words used in this specification to describe the invention andits various embodiments are to be understood not only in the sense oftheir commonly defined meanings, but to include by special definition inthis specification the generic structure, material or acts of which theyrepresent a single species.

The definitions of the words or elements of the following claims are,therefore, defined in this specification to not only include thecombination of elements which are literally set forth. In this sense itis contemplated that an equivalent substitution of two or more elementsmay be made for any one of the elements in the claims below or that asingle element may be substituted for two or more elements in a claim.Although elements may be described above as acting in certaincombinations and even initially claimed as such, it is to be expresslyunderstood that one or more elements from a claimed combination can insome cases be excised from the combination and that the claimedcombination may be directed to a subcombination or variation of asubcombination.

Insubstantial changes from the claimed subject matter as viewed by aperson with ordinary skill in the art, now known or later devised, areexpressly contemplated as being equivalently within the scope of theclaims. Therefore, obvious substitutions now or later known to one withordinary skill in the art are defined to be within the scope of thedefined elements.

The claims are thus to be understood to include what is specificallyillustrated and described above, what is conceptionally equivalent, whatcan be obviously substituted and also what incorporates the essentialidea of the invention.

1. A method for making a package for an elongate surgical device havingan outside diameter, comprising the steps of: providing an elongate tubehaving a first end, a second end, and a tube wall with an insidediameter greater than the outside diameter of the device; coiling thetube to move a first tube portion into an adjacent relationship with asecond tube portion; attaching the first end of the tube to a fixturehaving a heating element; moving the tube with respect to the heatingelement, or the heating element with respect to the tube; and bondingthe tube walls of the adjacent tube portion without occluding the tubeto form a fixed relationship between the first tube portion and theadjacent second tube portion, and to maintain the tube in a coiledconfiguration.
 2. The method recited in claim 1 wherein the bonding stepincludes the step of thermally bonding the tube portions to form atleast one weld between the tube portions.
 3. The method recited in claim1 wherein the bonding step includes the step of: joining the tubeportions with a bridge; and bonding the bridge to the first tube portionand the second tube portion.
 4. The method recited in claim 1 furthercomprising the step of: providing a backing card; and attaching the tubein the coiled configuration to the backing card.
 5. The method recitedin claim 1 wherein the coiling step includes the step of forming thetube into a plurality of coils having a common diameter and defining astack of coils.
 6. The method recited in claim 5 wherein the bondingstep includes the step of bonding the adjacent tube portions at aplurality of discreet locations around the stack of coils.
 7. The methodrecited in claim 5 wherein the bonding step includes the step of weldingthe adjacent coil portions to form a single continuous weld around thestack of coils.
 8. The method recited in claim 1 further comprising thestep of: inserting the surgical device into the tube in the coiledconfiguration.
 9. A method for making a package for an elongate surgicaldevice, comprising the steps of: providing an elongate tube having wallsdefining a lumen between a first end and a second end of the tube;attaching the first end of the tube to a fixture having at least oneheating station and a turntable rotatable relative to the heatingstation; rotating the turntable to form the tube into at least one coilhaving adjacent coiled portions; and bonding the adjacent coiledportions as they rotate by the heat station.
 10. The method recited inclaim 9 wherein the rotating step includes the step of forming the tubeinto a stack of coils.
 11. The method recited in claim 10 wherein thebonding step includes the step of bonding each of the coils in the stackof coils to an adjacent coil in the stack of coils to form at least onethermal bond.
 12. The method recited in claim 9 further comprising thestep of: heating the adjacent coil portions to thermally bond the coilportions.
 13. The method recited in claim 12 wherein the heating stepincludes the step of directing heated air onto the adjacent coiledportions.
 14. The method recited in claim 12 wherein the heating stepincludes the step of contacting the adjacent coiled portions with aheating element.
 15. The method recited in claim 12 wherein the applyingstep includes the step of directing a laser beam onto at least one ofthe adjacent coiled portions.
 16. The method recited in claim 12 whereinthe heating step includes the step of: plastisizing the adjacent coiledportions to form a non-peelable bond between the adjacent coiledportions.
 17. The method recited in claim 9 further comprising the stepof thermally bonding a retention accessory to the tube.
 18. The methodrecited in claim 9 further comprising the step of thermally bonding abacking card to the tube.